Kurzfassung

The purpose of this Phase 3 study is to assess the efficacy and safety of aducanumab compared with placebo in subjects with early Alzheimer’s Disease (AD), including subjects with mild
cognitive impairment (MCI) due to AD and a subset of mild AD.
Aducanumab is a human monoclonal antibody that recognizes
aggregated forms of β-amyloid (Aβ), including soluble Aβ
oligomers and deposited fibrillar Aβ. Interim analyses of the
ongoing multiple dose study (Study 221AD103) have
demonstrated target...
The purpose of this Phase 3 study is to assess the efficacy and safety of aducanumab compared with placebo in subjects with early Alzheimer’s Disease (AD), including subjects with mild
cognitive impairment (MCI) due to AD and a subset of mild AD.
Aducanumab is a human monoclonal antibody that recognizes
aggregated forms of β-amyloid (Aβ), including soluble Aβ
oligomers and deposited fibrillar Aβ. Interim analyses of the
ongoing multiple dose study (Study 221AD103) have
demonstrated target engagement, a pharmacodynamic effect on
amyloid reduction, and an effect on the Clinical Dementia Rating
(CDR)-Sum of Boxes (SB) and Mini-Mental State Examination
(MMSE) suggestive of a reduction in the progression of clinical
impairment for aducanumab-treated subjects. These results along
with the observed safety and tolerability profile warrant further
Phase 3 investigation of aducanumab in a patient population
spanning the early stages of the AD continuum.
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